646   Body Shape Abnormalities in a Cohort of HIV- Infected Patients on First-Line HAART.

R. Rubio*¹, M. Torralba¹, A. Antela², F. Dronda², R. Costa², and S. Moreno².
¹Hosp. 12 de Octubre and²Hosp. Ramón y Cajal, Madrid, Spain.

Background:Few studies have investigated the development of, and factors associated with, body shape changes in patients who have been on stable first-line therapy for prolonged periods.

Methods:We studied a cohort of 124 patients who initiated therapy after 1/1/97 and did not switch any of the components of the antiretroviral regimens. Patients were evaluated at baseline (day of inclusion in the study) and have been followed every 6 months. Evaluations include anthropometric measurements and laboratory determinations (triglycerides, cholesterol, glucose, CD4 count, viral load). At baseline, changes in body shape were evaluated by the patient and by a physician or a nurse who was unaware of the treatment regimen the patient was receiving. Severity of body changes was scored as 0 (no changes), 1 (mild), 2 (moderate), and 3 (severe), for both lipoatrophy and lipoaccumulation.

Results:At the time of inclusion in the study, mean age was 37.7 years and 25% were female. Risk factors for HIV infection included intravenous drug use in 60% and sexual risk practices in 35%. Median viral load (VL) and CD4 count at the start of therapy were 4.43 log and 238 cells/mm³

respectively. After a median of 21.5 (6—72) months in the same antiretroviral regimens, the prevalence of body shape abnormalities (moderate to severe) was 18% overall (7% lipoatrophy, 9% lipoaccumulation, 2% mixed). The estimated incidence was 10% for every year of antiretroviral therapy (4%, 5%, and 1% for lipoatrophy, lipoaccumulation, and mixed abnormalities, respectively). In multivariate analysis, no factors could be identified that increase the risk for development of body shape abnormalities. In particular, no association was found with the use of protease inhibitors (OR 1.83, 95% CI 0.3—12.8) or any nucleoside analogue [zidovudine (OR 0.56, 95% CI 0.1—2.4), stavudine (OR 1.2, 95% CI 0.4 —7.5), or lamivudine (OR 0.7, 95% CI 0.1—3)].

Conclusions:We have observed a relatively low prevalence (18%) and incidence (10% per year) of clinically significant body shape abnormalities in patients who have never switched their initial antiretroviral regimen. We have not been able to identify specific risk factors, including any particular antiretroviral drug.